RECRUITING

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Description

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

Conditions

Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis
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Related Conditions:

Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis

Study Overview

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Study Details

Study overview

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Condition
Primary Myelofibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center, Birmingham, Alabama, United States, 35294

Phoenix

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Los Angeles

UCLA David Geffen School of Medicine, Los Angeles, California, United States, 90095

Aurora

University of Colorado Cancer Center, Aurora, Colorado, United States, 80045

Boulder

Rocky Mountain Cancer Centers (US Oncology/McKesson), Boulder, Colorado, United States, 80303

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06510

Washington

Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Washington

George Washington University-Medical Faculty Associates, Washington, District of Columbia, United States, 20037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Swedish Orphan Biovitrum,

    Simran Singh, STUDY_DIRECTOR, Sobi, Inc.

    Study Record Dates

    2025-12-31